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Introduction to Pharmacovigilance Writing

Level:
Foundation
Area:
Drug Development
Code:
DDF32a
Duration:
03:00:00
Workshop profile:
Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).
Objective:
After completing this workshop, participants will have basic understanding of the different PV documents required by the regulatory authorities both prior to marketing and post-marketing. They will understand the purpose of the documents, when they are required, how they interact and overlap with each other and what guidance is available to help in preparation of them. In addition, they will be introduced to the difference of the safety data collected in clinical trials and post-marketing.
Content:
In depth document content and format is covered in other document-specific workshops. This workshop will provide a basic overview of RMP, DSUR and PBRER, and explain the standard terms and definitions routinely used in PV documents. It will discuss overlaps and links between these documents, available guidance, when and why the documents are needed, who uses them, and what the roles medical writers in clinical development and PV have in developing the documents.